EDC Software System Validation& Foreign Laboratory GCP Certification

  • April 1, 2019
  • Posted by: AXSource
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Client Type: Software & Computer System Validation, GxP System

Jurisdiction(s): USA

Services Provided: Completed computer system validation for FDA Part 11 compliance. Prepared for the FDA audit and conducted the on-site audit at the vendor site. Assessed conformance to FDA requirements for validation and GCP conformity and issued a final report.